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The Additive Orthopaedics Bunion System is indication and fusion of fractures, ostotomies and arthrodesis of small bones such as the foot and ankle.
The Additive Orthopaedics Bunion System is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.

The Additive Orthopaedics Bunion System consists of a plate and screws (both locking and nonlocking) with surgical site preparation and insertion instruments. The devices is intended to be used for fixation following an osteotomy in bunion correction procedures. The plates are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The screws are manufactured from medical grade titanium alloy. (Ti-6AL-4V). The implants are provided sterile and intended for single use only. The bunion plate comes in 1 individual size and the screws come in 4 lengths.

The provided document is a 510(k) premarket notification for a medical device called the "Additive Orthopaedics Bunion System." This document does not describe a study involving an AI/Machine Learning device and human readers, nor does it provide acceptance criteria and performance metrics in the way requested for such studies.

This document describes a traditional medical device (metallic bone fixation appliances) and focuses on demonstrating substantial equivalence to pre-existing predicate devices through mechanical testing and comparison of technological characteristics.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, MRMC studies, or training sets, as these are not relevant to the content of this 510(k) submission.

Key takeaway from the document:

• Device: Additive Orthopaedics Bunion System (plate and screws for bone fixation).
• Purpose: To demonstrate substantial equivalence to legally marketed predicate devices for the indication of alignment, stabilization, and fusion of fractures, osteotomies, and arthrodesis of small bones (foot and ankle).
• Methods of demonstration: Comparison of technological characteristics (indications, dimensions, geometry, materials, manufacturing process) and mechanical testing (4-point bending per ASTM F382, static driving torque, removal torque, static axial pullout per F543).
• Conclusion: The device is substantially equivalent to the predicate devices and is expected to perform at least as well.

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